Drip or spray devices for dispensing two or more synthetic or biologics based sealant components are known. In the medical device field, such devices are typically used for applying bioadhesives, polymers and other synthetic materials used as wound closures. Because of the reactant nature of the biocomponents used to form the bioadhesive blends, mixing of the components does not occur until the solution is ready to be applied. Mixing of the components too soon before application may result in premature hardening of the mixture, thereby making application of the solution impossible. Thus, in known spray or drip devices, the two or more components are maintained separately until just prior to application. The drip devices include one or more mixing means for mixing the two or more components prior to application. The mixing means may be passive, i.e., spiral configuration in the tubing, or instead may be active, i.e., mixing blade or impeller, with active mixing requiring more complex devices design. Once mixed, the solution may be applied through a needle-like output or may instead be ejected through a spray assembly. Thorough mixing of the two or more components prior to application is important to ensure that the solution will perform as intended.
An exemplary device is taught in U.S. Pat. No. 5,116,315, entitled “Biological Syringe System”, which discloses a system for delivery two fluids in a mixed composition, comprising a manifold and a discharge assembly. The discharge assembly mixes fluids in a mixing space and then atomizes the mixed fluids in a spray delivered from the assembly. Similarly, the device shown in U.S. Pat. No. 5,605,255, entitled, “Apparatus for Spraying a mixture of Two Components”, is an apparatus for spraying a liquid mixture having two syringes, a connecting piece, a premixing chamber, and a reduced volume section downstream from premixing chamber, and an exit aperture for spraying the mixture. The reduced volume section terminates in a homogenization region. U.S. Pat. No. 6,063,055, entitled “Turbulence Mixing Head for a Tissue Sealant Applicator and Spray Head for Same”, illustrates a device in which the mixing is performed in a mixing head.
Intermittent use of a biologics spray device, as may be required during a procedure, tends to clog the outlet of the applicator tip. As a result, most applicator assemblies are provided with a number of replacement tips for use when clogging of the tip occurs. Replacing clogged applicator tips interrupts the flow of a procedure, is time consuming and is an added expense. The device in published U.S. Publication 2010/0096481, “Self-Cleaning Spray Tip”, is described as having the distal end of spray cap assembly with an outlet that changes its configuration—at rest and at a second condition (e.g. during expression). The distal end is described as comprised of a material that permits flexion and expansion. The first and second reactive components are introduced into swirl chambers before mixing and are atomized as ejected through the outlet in a cone-shaped spray
U.S. Pat. No. 5,605,541 “Fibrin sealant applicator” discloses a device for applying a fibrin sealant comprising two components which will form said sealant when combined, which device comprises commonly actuable reservoirs for each of said components and a source of gas, wherein each of said reservoirs and said gas in separate fluid communication via a discrete channel to a spray head, said spray head having a first aperture located centrally in an exit end of said spray head through which said gas is discharged, said spray head having a first annular aperture in the exit end of said spray head within first annular aperture is concentric with said first aperture and through which one of said fibrin-sealant-forming components is discharged, and a second annular aperture in the exit end of said spray head being concentric with said first aperture and concentric with, and having a radius larger than said first annular aperture through which the second of said fibrin-sealant-forming components is discharged wherein all of said apertures are in a common plane.
U.S. Pat. No. 6,773,414 “Device and method for dispensing at least two mutually reactive components” discloses a device for dispensing at least two mutually reactive components, comprising a component supplier having primary channels for supplying respective ones of said at least two reactive components to a component dispenser having secondary channels for separately discharging said at least two reactive components through orifices opening into a free target area at a distal tip end of the dispenser for external intimate mixing of the respective reactive components outside a distal tip end of said dispenser, wherein distributors are interposed between said primary and secondary channels for multiplying the number of each respective primary channel with at least a factor 2, adjacent ones of said orifices of said secondary channels being adjoined to said primary channels intended for supply of reactive components of different kind.
U.S. Pat. No. 7,018,357 “External mixer assembly” discloses a fluid delivery system for dispensing a multicomponent biological adhesive having at least a first component and a second component, the system comprising:
a housing configured to receive a plurality of reservoirs;
a discharge nozzle housing a conduit assembly having a plurality of conduits with a proximal end thereof in respective fluid communication with separate of said reservoirs, a distal end of said conduits defining at least two exit openings, wherein each of said plurality of reservoirs includes a sealable opening configured for being penetrated by a proximal end of a respective one of said plurality of conduits; anda deflector assembly provided on said housing, said deflector assembly having a deflector plate substantially parallel with said at least two exit openings, said deflector plate displaced at a distance from a distal-most end of said housing and oriented to deflect said first and second components after exiting from said at least two exit openings.
U.S. Pat. No. 8,616,468 “Spray applicator” discloses a spray assembly for dispensing a mixture, the assembly comprising: a connector configured for operable engagement with a first source of component and a second source of component; an elongated member operably connected to and extending distally from the connector, the elongated member including an inner shaft and an outer sleeve, and defining a vent lumen between the inner shaft and outer sleeve, the inner shaft defines at least a first lumen configured for fluid communication with the first source of component and a second lumen configured for fluid communication with the second source of component; a tip operably connected to the connector, the tip including an opening and defining a mixing chamber between a distal end of the elongated member and the opening of the tip; and an insert member configured to be received in the mixing chamber, the insert member defining at least one radially extending slot on a first end of the insert member and at least one radially extending slot on a second end of the insert member, each of the radially extending slots being configured to mix the first and second components prior to the combination exiting the opening in the tip.
There is a need in conveniently changing spray or drip tips to avoid procedure interruption if/when clogging of the tip occurs. Particularly in laparoscopic procedures, clogged tips may result in significant and undesirable delays in delivery of the sealant or hemostat.